RFA-NS-02-006: R21 FAST TRACK GRANTS FOR PARKINSON"S DISEASE RESEARCH

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R21 FAST TRACK GRANTS FOR PARKINSON"S DISEASE RESEARCH Release Date: May 17, 2001 RFA: RFA-NS-02-006 The National Institute of Neurological Disorders and Stroke The National Institute on Deafness and Other Communication Disorders The National Institute of Environmental Health Sciences The National Institute of Mental Health The Michael J. Fox Foundation for Parkinson"s Research The Parkinson’s Disease Foundation/National Parkinson’s Foundation The Parkinson’s Alliance Letter of Intent Receipt Date: June 13, 2001 Application Receipt Date: July 19, 2001 THIS RFA USES THE "MODULAR GRANT" AND "JUST-IN-TIME" CONCEPTS. IT INCLUDES DETAILED MODIFICATIONS TO STANDARD APPLICATION INSTRUCTIONS THAT MUST BE USED WHEN PREPARING APPLICATIONS IN RESPONSE TO THIS RFA. PURPOSE The National Institute of Neurological Disorders and Stroke (NINDS), The National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Mental Health (NIMH), the Michael J. Fox Foundation for Parkinson"s Research, the Parkinson’s Disease Foundation/National Parkinson’s Foundation, and the Parkinson’s Alliance invite investigator-initiated grant applications to conduct research relevant to the cure, cause, prevention or improved treatment of Parkinson’s Disease (PD) and its complications. The intent of this RFA is to stimulate novel, innovative, or high impact approaches to the field of Parkinson"s Disease research within the framework of the exploratory/developmental granting mechanism to enhance and escalate discoveries beneficial to PD. RESEARCH OBJECTIVES Background One of the highest priority goals in the mission of the National Institute of Neurological Disorders and Stroke (NINDS) is to encourage research in neurodegeneration over the entire life span from birth to the last years of life. As a part of that mission, the NINDS has written a 5-year plan to escalate progress in the treatment, prevention or cure of Parkinson"s Disease (see the website: http://www.ninds.nih.gov/about_ninds/plans/nihparkinsons_agenda.htm). Parkinson"s Disease is the most common neurodegenerative movement disorder, and is caused by selective degeneration of the dopaminergic neurons of the substantia nigra, a brain area critical for purposeful control of movement. When the level of striatal dopamine falls below 20% as the result of nigrostriatal degeneration, the symptoms of the disease appear, including tremor, bradykinesia, gait abnormality, and postural instability. With progression of the disease, further complications can arise such as cognitive impairment or dementia, depression, and perturbations of the autonomic nervous system. People with Parkinson"s Disease often experience difficulties in communication abilities and swallowing function, an area which is of strong priority to the National Institute on Deafness and Other Communication Disorders (NIDCD). The burden of Parkinson"s Disease and related parkinsonisms is extraordinarily devastating to individuals, to families, and to the nation. Approximately 1 percent of the population over age 50, suffer from PD. Scope The purpose of this RFA is to invite investigator initiated applications focused on advancing our understanding of Parkinson"s Disease as relevant to its treatment, cause, prevention, or cure. Investigators with diverse scientific interests are invited to direct their expertise to both basic and applied research. The intent is to enhance our understanding of the genetic and environmental causes of PD, to develop appropriate models relevant to understanding and treating the disease, and to develop innovative strategies to prevent, limit, or reverse the pathogenesis of PD. Applications may focus on epidemiology, genetics, biochemistry, cell biology, physiology, or clinical studies. An important component of disease cure or prevention is the translation of basic discoveries to their eventual application to the patient, so studies utilizing translational or "bench-to- bedside" approaches are encouraged. Collaborative efforts between of basic neurobiologists and clinicians are welcomed. A special area of interest for NIEHS is the role of environmental agents in the causation of Parkinson’s disease including the interactions of environmental agents with potential susceptibility genes and the development of novel animal models that could facilitate understanding environmental inputs in the etiology of the disease. The NIEHS would be especially interested in applications responsive to this RFA focused on these areas. A major priority in the NIDCD strategic plan is the development and improvement of devices, pharmacologic agents, and strategies for habilitation/rehabilitation of human communication disorders. The NIDCD would be specifically interested in applications responsive to this RFA focused on the areas of dysarthria and dysphagia. SPECIAL REQUIREMENTS Letter of Authorization Because the domestic applications will be co-funded by the NIH and the Foundations, all applicants should submit a brief letter to the NIH indicating that the application and the summary statements for such applications can be shared with the Foundations. Letters of authorization should be prepared by the principal investigator and co- signed by the official signing for the applicant organization. This letter may be combined with the Letter of Intent (see below) or may be submitted as a cover letter accompanying the application. Periodic Meetings Upon initiation of this program, the NIH and the Foundations plan to sponsor periodic meetings to encourage exchange of information among investigators, to foster collaborative efforts among program grantees, and to identify resources that would enhance the productivity of grantees. For this purpose, applicants should request travel funds for a two-day meeting each year, the location of which will be announced. Applicants should also include a statement in their applications indicating their willingness to participate in such meetings and to cooperate with other researchers. MECHANISM OF SUPPORT This RFA will use the National Institutes of Health (NIH) Exploratory/Developmental research grant (R21) award mechanism. Instructions for preparing the R21 grants are found at: http://www.ninds.nih.gov/funding/r21guidelines.htm. The R21 mechanism requires much less preliminary data than other funding mechanisms, and encourages newcomers to the field, and also high-risk, high-impact hypotheses. Please note that the instructions limit the Research Plan to 15 pages. For the purposes of this RFA, the Research Plan is limited to 10 pages. Color/glossy figures are permitted when needed to show information. FUNDS AVAILABLE For FY 2002, the NINDS will commit $1.5 million (total costs) to fund new applications submitted in response to this RFA. The Fox Foundation will commit $500,000, and the Parkinson’s Disease Foundation/National Parkinson’s Foundation and the Parkinson’s Alliance will contribute $500,000. Pursuant to receipt of applications within their scientific interest, the NIDCD intends to commit approximately $400,000, NIMH intends to commit $500,000 and the NIEHS will commit $400,000. All awards will be issued by the NIH. An applicant may request a project period of up to 2 years and a budget for direct costs of up to $125,000 per year. Because the nature and scope of the research proposed may vary, it is anticipated that the size of each award will also vary. Although the financial plans of the NINDS and the Foundations provide support for this program, awards pursuant to this RFA are contingent upon the availability of funds and the receipt of a sufficient number of applications high scientific merit. At this time, it is not known if this RFA will be reissued. Competitive renewals of grants awarded under this program will not be accepted. ELIGIBILITY REQUIREMENTS Applications may be submitted by domestic and foreign, for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of state and local governments, and eligible agencies of the federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as Principal Investigators. INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: Diane D. Murphy, Ph.D. Program Director, Neurodegeneration, NINDS NSC Rm. 2223 6001 Executive Blvd. Bethesda, MD 20892 Tel: (301) 496-5680 Fax: (301) 480-1080 Email: murphyd@ninds.nih.gov Lana Shekim, Ph.D. Program Director, Voice & Speech, Scientific Programs Branch, DER National Institute on Deafness and Other Communication Disorders, NIH 6120 Executive Blvd., EPS-400-C MSC 7180 Bethesda, MD 20892-7180 Tel: 301-496-5061 Fax: 301-402-6251 Email: shekiml@nidcd.nih.gov Dr. Steven Zalcman Chief, Clinical Neuroscience Research Branch NIMH/Division of Neuroscience and Basic Behavioral Science 6001 Executive Blvd., Room 7177 MSC 9639 Bethesda, MD 20892-9639 Tel: 301-443-1692 Fax: 301-443-4822 Email: sz7f@nih.gov Dr. Annette Kirshner Health Scientist Administrator NIEHS MD EC-23 P.O. BOX 12233 RTP, NC 27709 Tel: (919) 541-0488 Fax: (919) 541-5064 Email: kirshner@niehs.nih.gov Dr. Cindy Lawler Health Scientist Administrator NIEHS MD EC-23 P.O. BOX 12233 RTP, NC 27709 Tel: 919 316-4671 Fax: (919) 541-5064 email: lawler@niehs.nih.gov Direct inquiries regarding review to: Dr. Lillian Pubols Chief, Scientific Review Branch, NINDS, NIH Neuroscience Center, Suite 3208 MSC9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Rockville, MD 20852 (for express/courier service) Telephone: 301/496-9223 Email: pubolsl@ninds.nih.gov Direct inquiries regarding fiscal and administrative matters to: Carlos Pena, Ph.D. Program Analyst, Neurodegeneration, NINDS Neuroscience Center 6001 Executive Blvd., Room 2228 Bethesda, MD 20892 Telephone: (301) 496-5680 Fax: (301) 480-1080 Email: penac@ninds.nih.gov Kimberly Pendleton Grants Management Specialist Grants Management Branch, DER, NINDS Neuroscience Center 6001 Executive Blvd., Room 3290 Bethesda, MD 20892-9537 Telephone: (301) 496-9231 FAX: 301-402-0219 EMAIL: kp33e@nih.gov LETTER OF INTENT Prospective applicants are asked to submit, by June 13, 2001, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NINDS staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent should be faxed or emailed to: Dr. Diane D. Murphy Program Director, Neurodegeneration Division of Extramural Activities National Institute of Neurological Disorders and Stroke NSC Rm. 2223 6001 Executive Blvd. Rockville, MD 20852 Phone (301) 496-5680 Fax (301) 480-1080 Email: murphyd@ninds.nih.gov SCHEDULE SUMMARY: Letter of Intent Receipt Date: June 13, 2001 Application Receipt Date: July 19, 2001 Initial Review: August 2001 Second Level Review: September 2001 Earliest Anticipated Date of Award: December 1, 2001 APPLICATION PROCEDURES The research grant application form PHS 398 (rev. 4/98) is to be used in applying for these grants. These forms are available at most institutional offices of sponsored research and may be obtained from the Division of Extramural Outreach and Information Resources, National Institutes of Health, 6701 Rockledge Drive, Suite 6095, Bethesda, MD 20892-7910, telephone 301-710-0267, email: GrantsInfo@nih.gov. All applicants should use the NINDS guidelines for the R21 mechanism at the url: http://www.ninds.nih.gov/funding/r21guidelines.htm. These guidelines contain important information on the suggested format of applications and on review criteria. The RFA label available in the PHS 398 (rev. 4/98) application form must be affixed to the bottom of the face page of the application. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. Submit a signed, typewritten original of the application, and 3 photocopies, including the Checklist in one package to: CENTER FOR SCIENTIFIC REVIEW NATIONAL INSTITUTES OF HEALTH 6701 ROCKLEDGE DRIVE, ROOM 1040 - MSC 7710 BETHESDA, MD 20892-7710 BETHESDA, MD 20817 (for express/courier service) At time of submission, 2 additional copies of the application must be sent to: Dr. Lillian Pubols Chief, Scientific Review Branch, NINDS, NIH Neuroscience Center, Suite 3208 MSC9529 6001 Executive Blvd. Bethesda, MD 20892-9529 Rockville, MD 20852 (for express/courier service) Telephone: 301/496-9223 Email: pubolsl@ninds.nih.gov Applications must be received by July 19, 2001. If an application is received after that date, it will be returned to the applicant without review. Similarly, supplemental documents containing significant revision or additions will not be accepted after that date. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. The CSR will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of substantial revisions of applications previously reviewed, but such applications must include an introduction addressing the previous critique. SPECIFIC INSTRUCTIONS FOR MODUALR GRANT APPLICATIONS Specific application instructions have been modified to reflect "MODULAR GRANT" and "JUST-IN-TIME" streamlining efforts being examined by the NIH. Complete and detailed instructions and information on Modular Grant applications can be found at: http://grants.nih.gov/grants/funding/modular/modular.htm. Responsibility for the planning, direction, and execution of the proposed project will be solely that of the applicant. The total project period for an application submitted in response to this RFA may not exceed two years and the funding for each year may not exceed $125,000 in direct costs. The anticipated award date is December 1, 2001. REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed for completeness by the CSR and responsiveness by NINDS. Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NINDS in accordance with NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit will be discussed, assigned a priority score, and receive a second level review by the National Institute of Neurological Disorders and Stroke Advisory Council. Review Criteria The goals of NIH-supported research are to advance our understanding of biological systems, improve the control of disease, and enhance health. In the written comments, reviewers will be asked to discuss the following aspects of the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed and considered in assigning the overall score, weighting them as appropriate for each application. Note that the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward. o Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? o Approach: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? o Innovation: Does the project employ novel concepts, approaches or method? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies? o Investigator: Is the investigator appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? o Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? In addition to the above criteria, in accordance with NIH policy, all applications will also be review with respect to the following: o The adequacy of plans to include both genders, minorities and their subgroups, and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. o The reasonableness of the proposed budget and duration in relation to the proposed research. o The adequacy of the proposed protection of humans, animals, or of the environment, to the extent that they may be adversely affected by the project proposed in the application. The initial review group will also examine the provisions for the protection of human subjects and the safety of the research environment. AWARD CRITERIA The earliest anticipated date of award is December 1, 2001. Awards will be based upon the following criteria: --scientific merit as determined by peer review --availability of funds --programmatic priorities of the funding institute INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification are provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the updated "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research," published in the NIH Guide for Grants and Contracts on August 2, 2000, available on the Internet at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-048.html The revisions relate to NIH defined Phase III clinical trials and require: a) all applications or proposals and/or protocols to provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable, and b) all investigators to report accrual, and to conduct and report analyses, as appropriate, by sex/gender and/or racial/ethnic group differences." INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS. It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: http://grants.nih.gov/grants/guide/notice-files/not98-024.html URLs IN NIH GRANT APPLICATIONS OR APPENDICES All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Reviewers are cautioned that their anonymity may be compromised when they directly access an Internet site. HEALTHY PEOPLE 2010 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This Request for Applications (RFA), R21 Fast Track Grants for Parkinson"s Disease Research, is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople/. AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance Nos. 93.853 (NINDS), 93.113 (NIEHS), 93.242 (NIMH), and 93.173 (NIDCD). Awards are made under authorization of Sections 301 and 405 of the Public Health Service Act (42 USC 241 and 248) and administered under NIH grants policies and Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

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